FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD INSULIN PUMP
MDR report key: 3952115
·
Received May 9, 2014
Report
- Report Number
- 3004464228-2014-00632
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- January 8, 2014
- Report Date
- May 3, 2014
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K122953
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE WAS EVALUATED AND NO EVIDENCE OF ANY MANUFACTURING DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO 40+ UNITS OF INSULIN IN SIZE, WAS FOUND IN THE INSULIN RESERVOIR. AS THERE WAS NO EVIDENCE THAT THE USER ATTEMPTED TO REMOVE RESIDUAL INSULIN, THIS WAS MOST LIKELY INTRODUCED DURING THE FILL PROCESS. USE ERROR IS THEREFORE, DETERMINED TO BE THE ROOT CAUSE OF THE HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTABLE CRITERIA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HAVING A HEADACHE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282221 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | L40709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |